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临床试验/NCT03084913
NCT03084913已完成不适用

Comparing Diets for Weight Loss and Improvement in Cancer Biomarkers in Men With Prostate Cancer

The Miriam Hospital0 个研究点目标入组 30 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
weight loss

研究概览

简要总结

This study compared a plant-based, olive oil diet to the diet recommended by the Prostate Cancer Foundation for weight loss and improvement in some laboratory biomarkers.

详细描述

Dietary treatment of overweight/ obese men with prostate cancer has not been well studied. As men with prostate cancer who are overweight/ obese are at an increase risk of recurrence, metastasis and mortality, elucidating a diet that will both improve biomarkers for prostate cancer and lead to long-term weight management could improve survivorship. The primary objective of this proposal is to compare a plant-based, olive oil (PBOO) diet to a conventional diet for weight loss and improvement in metabolic biomarkers (specifically fasting insulin, glucose, and triglycerides) for overweight/ obese men diagnosed with prostate cancer on surveillance or who have had an asymptomatic biochemical failure after primary therapy. The secondary objective is to determine which diet will be more acceptable for long term use. Participants will consume for 8 weeks each a conventional diet for treating prostate cancer and a PBOO diet for weight loss and improvement in biomarkers with random assignment to the diet order. They will choose one of the diets for 6 months of follow-up. Blood samples and body weight will be obtained pre- and post diet and after 6 months of follow-up and compared between the diets. Based on earlier work by colleagues of the PI, it is anticipated that the PBOO diet will result in better weight loss and biomarkers and will be more acceptable for long-term weight management. This protocol has the potential to elucidate a diet that will improve the body weight and survival of men with prostate cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • prostate cancer, BMI 25.0 to 40.0 kg/m2

排除标准

  • 未提供

研究组 & 干预措施

Prostate Cancer Foundation diet

Active Comparator

Intervention: 8-weeks of a Prostate Cancer Foundation diet

干预措施: Plant- based, olive oil diet (Other)

Prostate Cancer Foundation diet

Active Comparator

Intervention: 8-weeks of a Prostate Cancer Foundation diet

干预措施: Prostate Cancer Foundation diet (Other)

plant- based, olive oil diet

Experimental

Intervention: 8 weeks of a plant-based, olive oil diet

干预措施: Plant- based, olive oil diet (Other)

plant- based, olive oil diet

Experimental

Intervention: 8 weeks of a plant-based, olive oil diet

干预措施: Prostate Cancer Foundation diet (Other)

结局指标

主要结局

weight loss

时间窗: 8 weeks

次要结局

  • improvement in in fasting blood glucose and insulin(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Flynn

Research dietitian, Associate professor of Medicine

The Miriam Hospital

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